Beneficence - Protecting Human Subject Research Participants

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Protecting Human Research ParticipantsCodes and RegulationsMain Menu | Glossary | HelpCase Study: Human Heart StudyPrevious Page 9 of 19NextAn investigator will be using human hearts in order to study factorsleading to heart failure. One group of normal, control hearts will beobtained from cadavers. A set of diseased hearts will be obtained fromindividuals who are to receive a heart transplant.Does this study involve human subjects?Yes, this study involves human subjectsCorrect!The use of healthy hearts from cadavers does not constitute human subjects research, because theindividuals from whom the hearts will be obtained are not living, but the use of the diseased heartsremoved during transplant surgery is human subjects research, since the donors are alive.No, this study does not involve human subjectshttp://phrp.nihtraining.com/codes/09_codes.php (1 of 2)6/26/2008 2:34:55 PM
Protecting Human Research ParticipantsCodes and RegulationsMain Menu | Glossary | HelpAdditional ProtectionsPrevious Page 10 of 19NextThe Belmont principle of respect for persons states, in part, that individuals with diminished autonomymay need additional protections. Subparts B, C, and D describe additional protections for some of thepopulations that are considered particularly vulnerable:Subpart BAdditional Protections for Pregnant Women, Human Fetuses and Neonates Involved inResearchSubpart CAdditional Protections Pertaining to Biomedical and Behavioral Research Involving Prisonersas SubjectsSubpart DAdditional Protections for Children Involved as Subjects in Researchhttp://phrp.nihtraining.com/codes/10_codes.php (1 of 2)6/20/2008 9:16:04 AMPrevious Page 10 of 19Next
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Beneficence - Protecting Human Subject Research Participants

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